99.60 Withdrawal effective Apr 29, 2009
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.100 Laboratory medicine
This document describes a framework for the identification and, where necessary, quantification of the chemical constituents of a material to provide information required for inclusion in an assessment of the biological safety of medical devices. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993 part 9, 13, 14 and 15. ISO 10993-18 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.
Legislation related to this standard
WITHDRAWN
EN ISO 10993-18:2005
99.60
Withdrawal effective
Apr 29, 2009
WITHDRAWN
EN ISO 10993-18:2009